Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma

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The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma.

The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.

Condition or disease

Intervention/treatment

Phase

Exercise Induced Asthma

Drug: Budesonide/FormoterolDrug: Budesonide

Phase 4

Detailed Description:

The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma.

The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.

40 subjects will be randomized to receive both active medications in separate testing periods to determine the effect on their lung function after exercise testing.

This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide and dummy inhaler.

Drug: Budesonide/Formoterol

Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks

Other Name: Symbicort

Drug: Budesonide

Budesonide 180mcg, 2 puffs twice daily for 2 weeks

Other Name: Pulmicort

Active Comparator: Budesonide first

This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide/formoterol and dummy inhaler.

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Ages Eligible for Study:

12 Years to 50 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or Female Patients aged 12 to 50 years with a diagnosis of asthma for at least 6 months before screening

Baseline FEV1 of 60% to >100% of predicted

Demonstrate a decrease in FEV1 of 15% or greater from baseline after standardized stepped exercise challenge testing

Taking a constant dose of low-medium dose inhaled steroids for at least 30 days before screening of either:

Patients not able to safely complete an exercise challenge due to physical constraints outside of their respiratory status.

Patients who are pregnant or plan to become pregnant during the study period.

Patients with a history of hypersensitivity reaction to either formoterol or budesonide.

Patients with any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.

Patients with planned hospitalization during the study

Current Smokers or those with a history of 10 pack years of tobacco use or more.